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Efficacy and Safety Study of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma (DELTA)

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ClinicalTrials.gov Identifier: NCT01282424
Recruitment Status : Completed
First Posted : January 25, 2011
Results First Posted : September 4, 2014
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Follicular Lymphoma
Small Lymphocytic Lymphoma
Lymphoplasmacytic Lymphoma
Marginal Zone Lymphoma
Intervention Drug: Idelalisib
Enrollment 125
Recruitment Details Participants were enrolled at a total of 54 study sites in North America and Europe. The first participant was screened on 04 March 2011. The last participant observation for the Week 24 analysis was on 25 June 2013.
Pre-assignment Details 125 participants were enrolled and treated and comprise the Intent-to-Treat (ITT) Analysis Set.
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Period Title: Overall Study
Started 125
Completed: Disease Progression 41
Completed: Death 8
Completed 49
Not Completed 76
Reason Not Completed
Treatment Ongoing             40
Adverse Event             25
Withdrew Consent             4
Investigator Request             7
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Baseline Participants 125
Hide Baseline Analysis Population Description
ITT Analysis Set: Enrolled participants who received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants
62  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants
Female
45
  36.0%
Male
80
  64.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants
Hispanic or Latino
6
   4.8%
Not Hispanic or Latino
117
  93.6%
Unknown or Not Reported
2
   1.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants
White/Caucasian 110
Black or African American 2
Asian 3
American Indian or Alaska Native 1
Other 8
Unknown or Not Reported 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants
France 10
United States 83
Poland 8
Germany 10
United Kingdom 8
Italy 6
Karnofsky Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants
60 2
70 6
80 27
90 44
100 46
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses.
Baseline Disease History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants
Folicular lymphoma 72
Small lymphocytic lymphoma 28
LPL/WM 10
Marginal zone lymphoma 15
[1]
Measure Description: LPL/WM: Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia
1.Primary Outcome
Title Overall Response Rate
Hide Description

Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of subjects achieving a complete response (CR) or partial response (PR; or minor response [MR] for subjects with Waldenström macroglobulinemia [WM]) as assessed by the study independent review committee (IRC).

CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.

PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.

For WM only, response was defined as a reduction in IgM of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; plus any reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)

Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set: Enrolled participants who received at least one dose of study medication
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 125
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56.8
(47.6 to 65.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Idelalisib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The hypothesis is that the ORR is ≥ 39% (ie, ≥ ~40%) against the null hypothesis that it is ≤ 20%.
Method Exact binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Duration of Response
Hide Description Duration of Response (DOR) was defined as the interval from the first documentation of CR or PR (or MR for participants with WM) to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause.
Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set who achieved a CR or PR (or MR for subjects with WM) were analyzed.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 71
Median (Inter-Quartile Range)
Unit of Measure: months
12.5 [1] 
(4.5 to NA)
[1]
Not reached
3.Secondary Outcome
Title Lymph Node Response Rate
Hide Description Lymph node response (LNR) was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions as assessed by the study IRC.
Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 125
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53.6
(44.5 to 62.6)
4.Secondary Outcome
Title Time to Response
Hide Description Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR (or MR for participants with WM) as assessed by the study IRC.
Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set who achieved a CR or PR (or MR for subjects with WM) were analyzed.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 71
Median (Inter-Quartile Range)
Unit of Measure: months
1.9
(1.8 to 3.7)
5.Secondary Outcome
Title Progression-Free Survival
Hide Description Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause.
Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 125
Median (95% Confidence Interval)
Unit of Measure: months
11.0
(8.1 to 13.8)
6.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as the time interval from the start of idelalisib treatment to death from any cause.
Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 125
Median (95% Confidence Interval)
Unit of Measure: months
20.3 [1] 
(16.4 to NA)
[1]
Not reached
7.Secondary Outcome
Title Change in Health-related Quality of Life
Hide Description

Change in health-related quality of life events were reported by participants using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) assessment tool. Results are presented as the mean (SD) best change from baseline. The best change from baseline was defined as the highest change score (improvement) after baseline.

The FACT-LymS is on a scale from 0-60, with higher scores associated with a better quality of life. It incorporates values from 15 questions, each rated 0-4, related to study indications.

Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available data were analyzed.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 113
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.9  (7.89)
8.Secondary Outcome
Title Change in Karnofsky Performance Status
Hide Description The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.
Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available data were analyzed.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 122
Mean (Standard Deviation)
Unit of Measure: units on a scale
Best change 2.5  (8.58)
Worst change -9.3  (12.11)
9.Secondary Outcome
Title Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
Hide Description This composite endpoint measured the safety and tolerability profile of idelalisib. "Clinically meaningful" abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator.
Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: participants
Any AE 123
AE leading to drug discontinuation 30
Serious AE 64
Vital signs abnormal – clinically meaningful 0
ECG abnormal – clinically meaningful 0
Grade 3 or 4 hemoglobin 2
Grade 3 or 4 neutrophils 34
Grade 3 or 4 platelets 8
Grade 3 or 4 alanine aminotransferase 16
Grade 3 or 4 aspartate aminotransferase 10
10.Secondary Outcome
Title Study Drug Exposure
Hide Description The average idelalisib exposure was summarized.
Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: months
8.1  (5.72)
11.Secondary Outcome
Title Idelalisib Plasma Concentration
Hide Description [Not Specified]
Time Frame Predose and at 1.5 hours (± 5 minutes) postdose on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: ng/mL
Predose (n = 108) 471.6  (486.53)
Postdose (n = 106) 2187.7  (1050.76)
12.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Cmax
Hide Description Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.
Time Frame Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: Participants enrolled in the PK substudy were analyzed.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax at Day 1 2647.5  (1084.99)
Cmax at Day 29 2258.8  (809.61)
13.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Tmax
Hide Description Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).
Time Frame Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 8
Mean (Inter-Quartile Range)
Unit of Measure: hours
Tmax at Day 1
1.00
(0.99 to 1.04)
Tmax at Day 29
1.00
(0.95 to 2.00)
14.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: AUClast
Hide Description AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration
Time Frame Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: Participants enrolled in the PK substudy were analyzed.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: hours x ng/mL
AUClast at Day 1 9094.76  (2960.391)
AUClast at Day 29 9293.39  (3996.826)
Time Frame From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
All-Cause Mortality
Idelalisib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Idelalisib
Affected / at Risk (%)
Total   64/125 (51.20%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  4/125 (3.20%) 
Neutropenia  1  3/125 (2.40%) 
Anaemia  1  2/125 (1.60%) 
Anaemia haemolytic autoimmune  1  1/125 (0.80%) 
Splenic infarction  1  1/125 (0.80%) 
Thrombocytopenia  1  1/125 (0.80%) 
Cardiac disorders   
Cardiac failure  1  2/125 (1.60%) 
Atrial fibrillation  1  1/125 (0.80%) 
Sinus tachycardia  1  1/125 (0.80%) 
Supraventricular tachycardia  1  1/125 (0.80%) 
Cardiomyopathy  1  1/125 (0.80%) 
Acute myocardial infarction  1  1/125 (0.80%) 
Cardiac arrest  1  1/125 (0.80%) 
Gastrointestinal disorders   
Diarrhoea  1  9/125 (7.20%) 
Colitis  1  5/125 (4.00%) 
Melaena  1  2/125 (1.60%) 
Gastrointestinal haemorrhage  1  1/125 (0.80%) 
Upper gastrointestinal haemorrhage  1  1/125 (0.80%) 
Vomiting  1  2/125 (1.60%) 
Nausea  1  1/125 (0.80%) 
Pancreatitis  1  1/125 (0.80%) 
Abdominal pain  1  1/125 (0.80%) 
Enterocolitis  1  1/125 (0.80%) 
Acute abdomen  1  1/125 (0.80%) 
Haemorrhoids  1  1/125 (0.80%) 
Rectal haemorrhage  1  1/125 (0.80%) 
Oesophagitis  1  1/125 (0.80%) 
Mouth haemorrhage  1  1/125 (0.80%) 
Stomatitis  1  1/125 (0.80%) 
General disorders   
Pyrexia  1  13/125 (10.40%) 
Asthenia  1  2/125 (1.60%) 
Multi-organ failure  1  2/125 (1.60%) 
Oedema peripheral  1  2/125 (1.60%) 
Chest pain  1  2/125 (1.60%) 
Hepatobiliary disorders   
Cholelithiasis  1  1/125 (0.80%) 
Liver disorder  1  1/125 (0.80%) 
Immune system disorders   
Anaphylactic reaction  1  1/125 (0.80%) 
Autoimmune disorder  1  1/125 (0.80%) 
Infections and infestations   
Pneumonia  1  9/125 (7.20%) 
Bronchitis  1  1/125 (0.80%) 
Bronchopneumonia  1  1/125 (0.80%) 
Lung infection  1  1/125 (0.80%) 
Pneumonia necrotising  1  1/125 (0.80%) 
Gastroenteritis  1  1/125 (0.80%) 
Perirectal abscess  1  1/125 (0.80%) 
Rectal abscess  1  1/125 (0.80%) 
Septic shock  1  2/125 (1.60%) 
Sepsis  1  1/125 (0.80%) 
Sepsis syndrome  1  1/125 (0.80%) 
Cytomegalovirus colitis  1  2/125 (1.60%) 
Pneumonia cytomegaloviral  1  1/125 (0.80%) 
Herpes zoster  1  2/125 (1.60%) 
Device related infection  1  1/125 (0.80%) 
Wound infection  1  1/125 (0.80%) 
Pneumonia staphylococcal  1  1/125 (0.80%) 
Staphylococcal infection  1  1/125 (0.80%) 
Pharyngitis  1  1/125 (0.80%) 
Sinusitis  1  1/125 (0.80%) 
Urinary tract infection  1  2/125 (1.60%) 
Cellulitis  1  1/125 (0.80%) 
Pneumocystis jiroveci pneumonia  1  1/125 (0.80%) 
Lung infection pseudomonal  1  1/125 (0.80%) 
Soft tissue infection  1  1/125 (0.80%) 
Pneumonia streptococcal  1  1/125 (0.80%) 
Toxoplasmosis  1  1/125 (0.80%) 
Injury, poisoning and procedural complications   
Fracture  1  1/125 (0.80%) 
Hip fracture  1  1/125 (0.80%) 
Fall  1  1/125 (0.80%) 
Head injury  1  1/125 (0.80%) 
Metabolism and nutrition disorders   
Dehydration  1  4/125 (3.20%) 
Decreased appetite  1  1/125 (0.80%) 
Hypercalcaemia  1  1/125 (0.80%) 
Failure to thrive  1  1/125 (0.80%) 
Metabolic acidosis  1  1/125 (0.80%) 
Hypokalaemia  1  1/125 (0.80%) 
Hyponatraemia  1  1/125 (0.80%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/125 (0.80%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Gastric cancer  1  1/125 (0.80%) 
Second primary malignancy  1  1/125 (0.80%) 
Skin cancer  1  1/125 (0.80%) 
Nervous system disorders   
Cerebral ischaemia  1  1/125 (0.80%) 
Cerebrovascular accident  1  1/125 (0.80%) 
Paraplegia  1  1/125 (0.80%) 
Psychiatric disorders   
Anxiety  1  1/125 (0.80%) 
Renal and urinary disorders   
Renal failure acute  1  3/125 (2.40%) 
Renal mass  1  1/125 (0.80%) 
Hydronephrosis  1  1/125 (0.80%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  3/125 (2.40%) 
Pneumonia aspiration  1  2/125 (1.60%) 
Interstitial lung disease  1  2/125 (1.60%) 
Lung infiltration  1  1/125 (0.80%) 
Pleural effusion  1  2/125 (1.60%) 
Acute respiratory distress syndrome  1  2/125 (1.60%) 
Dyspnoea  1  1/125 (0.80%) 
Pulmonary embolism  1  1/125 (0.80%) 
Skin and subcutaneous tissue disorders   
Erythema  1  1/125 (0.80%) 
Dermatitis exfoliative  1  1/125 (0.80%) 
Rash  1  1/125 (0.80%) 
Vascular disorders   
Hypotension  1  2/125 (1.60%) 
Lymphorrhoea  1  1/125 (0.80%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Idelalisib
Affected / at Risk (%)
Total   121/125 (96.80%) 
Blood and lymphatic system disorders   
Neutropenia  1  33/125 (26.40%) 
Thrombocytopenia  1  20/125 (16.00%) 
Anaemia  1  13/125 (10.40%) 
Leukopenia  1  9/125 (7.20%) 
Gastrointestinal disorders   
Diarrhoea  1  53/125 (42.40%) 
Nausea  1  36/125 (28.80%) 
Abdominal pain  1  20/125 (16.00%) 
Vomiting  1  17/125 (13.60%) 
Constipation  1  10/125 (8.00%) 
Abdominal pain upper  1  9/125 (7.20%) 
Stomatitis  1  8/125 (6.40%) 
General disorders   
Fatigue  1  37/125 (29.60%) 
Pyrexia  1  29/125 (23.20%) 
Asthenia  1  12/125 (9.60%) 
Oedema peripheral  1  11/125 (8.80%) 
Chills  1  8/125 (6.40%) 
Mucosal inflammation  1  8/125 (6.40%) 
Pain  1  8/125 (6.40%) 
Infections and infestations   
Upper respiratory tract infection  1  18/125 (14.40%) 
Investigations   
Alanine aminotransferase increased  1  18/125 (14.40%) 
Weight decreased  1  17/125 (13.60%) 
Aspartate aminotransferase increased  1  15/125 (12.00%) 
Blood creatinine increased  1  8/125 (6.40%) 
Metabolism and nutrition disorders   
Decreased appetite  1  22/125 (17.60%) 
Hypokalaemia  1  10/125 (8.00%) 
Dehydration  1  8/125 (6.40%) 
Hyperglycaemia  1  8/125 (6.40%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  11/125 (8.80%) 
Nervous system disorders   
Headache  1  13/125 (10.40%) 
Dizziness  1  10/125 (8.00%) 
Dysgeusia  1  7/125 (5.60%) 
Psychiatric disorders   
Insomnia  1  12/125 (9.60%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  36/125 (28.80%) 
Dyspnoea  1  21/125 (16.80%) 
Oropharyngeal pain  1  10/125 (8.00%) 
Skin and subcutaneous tissue disorders   
Rash  1  15/125 (12.00%) 
Night sweats  1  14/125 (11.20%) 
Pruritus  1  8/125 (6.40%) 
Dry skin  1  7/125 (5.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01282424     History of Changes
Other Study ID Numbers: 101-09
2010-022155-33 ( EudraCT Number )
First Submitted: January 21, 2011
First Posted: January 25, 2011
Results First Submitted: August 22, 2014
Results First Posted: September 4, 2014
Last Update Posted: November 19, 2018